Prevalence of Rheumatic Heart Disease Among Pregnant Women in Kenya

Pregnancy Related Clinical Trial

Official title:

Prevalence of Rheumatic Heart Disease in Pregnancy Among a Population of Antenatal Patients at a Tertiary Care Institution in Western Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411993
• Other study ID #: UMoi4
• Status: Completed
• Start date: January 31, 2018
• Est. completion date: March 12, 2018

Study information

• Verified date: July 2018
• Source: Moi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There is currently no routine screening for cardiac disease for pregnant women in areas of high prevalence. This study will aim to determine the point prevalence of cardiac disease in women presenting for antenatal care at Moi Teaching and Referral Hospital. More specifically, it will aim to use focused echocardiography as a screening tool to determine the prevalence of cardiac disease among pregnant women attending MTRH antenatal clinic.

Description:

Rheumatic heart disease (RHD) in pregnancy can be associated with severe maternal and neonatal morbidity and mortality. Early identification of these women and referral to specialized, multi-disciplinary care is essential. Overall, studies on RHD prevalence are lacking in sub-Saharan countries and a significant gap in the literature exists for the prospective assessment of disease in the context of pregnancy. At Moi Teaching and Referral Hospital, there are an estimated 3-4 cases per month of women presenting with acute exacerbations of either known or newly diagnosed cardiac disease. These women are often the most challenging clinically and emotionally for the reproductive health team to manage, and contribute to a significant number of the 2-3 maternal deaths per month at MTRH. There is currently no routine screening for cardiac disease in the MTRH antenatal clinics. This study will aim to determine the point prevalence of cardiac disease in women presenting for antenatal care at Moi Teaching and Referral Hospital. More specifically, it will aim to: 1. Use focused echocardiography as a screening tool to evaluate cardiac structure and function; 2. Use focused echocardiography as a screening tool to determine the prevalence of cardiac disease among pregnant women attending MTRH antenatal clinic.; 3. Determine the proportion of pregnant women with cardiac disease who endorse clinical symptoms as a potential means to develop a screening tool; 4. Promote a case-finding culture for cardiac disease in pregnancy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 612
• Est. completion date: March 12, 2018
• Est. primary completion date: March 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• pregnant women at any gestational age

• capable to give informed consent

Exclusion Criteria:

• medically unstable: any condition or complication resulting from or independent of pregnancy that necessitates urgent care or that precludes full and informed consent process

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• Pregnancy Related
• Rheumatic Heart Disease

Intervention

Diagnostic Test:
• Focused cardiac echography
All pregnant women attending antenatal care will be eligible to undergo focused cardiac echo to identify underlying cardiac disease

Locations

Country	Name	City	State
Kenya	Moi Teaching and Referral Hospital	Eldoret

Sponsors (5)

Lead Sponsor	Collaborator
Moi University	Duke University, Moi Teaching and Referral Hospital, Mount Sinai Hospital, Canada, Mount Sinai Hospital, New York

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac disease	Point prevalence of cardiac lesions identifiable by cardiac echo	through study completion, an average of 3 months